[Answered] Critically analyze the regulatory process for new drugs and vaccines in India. How can this process be streamlined to ensure safety while also allowing for flexibility in times of crisis?

Recently, the WHO gave the Indian vaccine regulatory structure the highest rating on various parameters. The rating point to the fact that India is a stringent regulator of vaccines alongside developed countries such as the US, Japan, and EU member states. The regulatory process in India aims to ensure the efficiency, quality, affordability, and safety of pharmaceutical products.

What are certain factors on which the regulatory process can be analyzed?

• Central Drugs Standard Control Organization (CDSCO): CDSCO is in charge of licensing new medications and vaccines in India. It gives marketing permits, manages post-marketing safety, and supervises the clinical trial approval procedure.
• Clinical Trials: These are done to ensure the efficacy and safety of the drug.  Mistrust, arbitrary decree, and lax regulations have historically plagued clinical trials in India.
• Delay in approval: In India, the procedure for receiving regulatory approval can be time-consuming. In urgent situations like epidemics or emergencies, approval delays might prevent timely access to life-saving medicines and vaccinations.
• Lack of evidence-based assessment: India’s regulatory framework has been primarily focused on analyzing formulations that have received foreign regulatory approval and determining if they are appropriate for India. This can also be seen in the adoption of ‘emergency use authorizations (EUA) during COVID-19.
• Inadequate regulation: Poor regulation often floods the market with poor-quality and fake medications. They may not meet efficiency, safety, and potency standards and may endanger life of patients. The detection and reduction of possible dangers associated with pharmaceutical products are further hampered by inadequate monitoring of adverse drug reactions and post-market surveillance.

What steps can be taken to ensure safety and maintain flexibility during the crisis?

• Strengthen regulatory agencies: Augment the resources and capacity building of regulatory agencies like CDSCO and the Drug Controller General of India.
• New Drugs and Clinical Trials Rules: The rules should be updated and framed in light of the recent COVID pandemic. There should be clear guidelines on the process to be followed during exigencies and the process be evidence-based.
• Transparency and Standardized testing: India’s regulatory system requires transparency between consumers and regulatory agencies. Standardized testing is essential to ensuring the safety and effectiveness of medicines.
• Single regulatory agency:  The establishment of a single regulatory body will enhance oversight and quicken the approval process for medications. A centralized organization can offer uniform regulatory enforcement, homogeneous standards, and efficient industry oversight.
• Pharmacovigilance: The current gaps in the regulatory landscape can be filled by creating effective pharmacovigilance programs and encouraging transparency and accountability. The need is to establish strong quality checks, efficient inspection processes, and strong regulatory frameworks.

Conclusion:

The estimated value of total vaccines manufactured in India is around $ 900 million out of which 65%-70% is exported. The above-listed measures will make Indian pharma companies competitive, increase their export share and bring the quality of medicines at par with the global industry earning India the title of “pharmacy of the world.”